FDA.reportPublic FDA data

Lospa Modular Knee System

Primary DI
08806373865725
Brand
Lospa Modular Knee System
Company
Corentec Co., Ltd
Model
K2.OFT.1502-ASY
Device description
OFFSET ADAPTOR WITH NUT-L02
Published
2024-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160157000LOSPA Modular Knee SystemCorentec Co., Ltd.2016-12-01JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373865725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373865725088063738657258806373865725

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur stem prosthesisA sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82269374902ra@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800068946966BENCOXHA.018.28352026-07-01
08800068946973BENCOXHA.018.40622026-07-01
08800068963666BENCOXHA.018.36422026-07-01
08806373897344BENCOXHA.018.28372026-07-01
08806373897351BENCOXHA.018.32392026-07-01
08806373897368BENCOXHA.018.36442026-07-01
08806373897375BENCOXHA.018.36482026-07-01
08806373897382BENCOXHA.018.36522026-07-01
08809945870332BENCOX InstrumentHA.014.00042024-04-24
08800068983558BENCOXHA.0B8.00012026-07-24
08800017271095BENCOXHA.02G.00012026-04-10
08800017269726EXULT Knee Replacement SystemK3.FAL.73762020-05-21
08800017269733EXULT Knee Replacement SystemK3.FAR.73762020-05-21
08800017269740EXULT Knee Replacement SystemK3.FAL.76782020-05-21
08800017269757EXULT Knee Replacement SystemK3.FAR.76782020-05-21
08800017269764EXULT Knee Replacement SystemK3.FBL.73762020-05-21
08800017269771EXULT Knee Replacement SystemK3.FBR.73762020-05-21
08800017269788EXULT Knee Replacement SystemK3.FBL.76782020-05-21
08800017269795EXULT Knee Replacement SystemK3.FBR.76782020-05-21
08800017260853EXULT Knee Replacement SystemK3.BFN.36572020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
E31442411410SignatureMaterialise NVJWH2026-09-24
E31442422415SignatureMaterialise NVJWH2026-09-24
E31442422450SignatureMaterialise NVJWH2026-09-24
E31442422451SignatureMaterialise NVJWH2026-09-24
E31442422452SignatureMaterialise NVJWH2026-09-24
E31442422453SignatureMaterialise NVJWH2026-09-24
E31442422455SignatureMaterialise NVJWH2026-09-24
E31442422456SignatureMaterialise NVJWH2026-09-24
E31442422457SignatureMaterialise NVJWH2026-09-24
E31442422458SignatureMaterialise NVJWH2026-09-24
E31442422460SignatureMaterialise NVJWH2026-09-24
E31442422461SignatureMaterialise NVJWH2026-09-24
E31442422462SignatureMaterialise NVJWH2026-09-24
E31442422463SignatureMaterialise NVJWH2026-09-24
E31442422465SignatureMaterialise NVJWH2026-09-24
E31442422466SignatureMaterialise NVJWH2026-09-24
E31442422467SignatureMaterialise NVJWH2026-09-24
E31442422468SignatureMaterialise NVJWH2026-09-24